The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Sonopet Iq Ultrasonic Aspirator System.
Device ID | K190070 |
510k Number | K190070 |
Device Name: | Sonopet IQ Ultrasonic Aspirator System |
Classification | Instrument, Ultrasonic Surgical |
Applicant | Stryker Corporation 4100 E. Milham Ave. Kalamazoo, MI 49001 |
Contact | Julia Helgeson |
Correspondent | Julia Helgeson Stryker Corporation 4100 E. Milham Ave. Kalamazoo, MI 49001 |
Product Code | LFL |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-01-15 |
Decision Date | 2019-04-11 |